Agency classClass IIOur severity:High FDA (Devices)·Z-2489-2018·Announced 2018-07-25

Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect

Cardinal Health 200, LLC is recalling Hydroline Trumpet Valves because the suction valve may not close properly, potentially causing continuous suction.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect (continuous suction) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Cardinal Health 200, LLC is recalling specific lots of Hydroline Trumpet Valves with Pulse Wave Cassette and Trumpet Valves with Double Spike and no Probe. The recall involves 63,020 units distributed to various states in the United States, the District of Columbia, and several foreign countries including Belgium, France, Germany, Israel, Italy, the Netherlands, Singapore, and the United Kingdom. Government and military distribution was also made.

The recall is being conducted because the suction valve may not close properly, which could cause continuous suction. This is a Class II recall, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Affected lots include 11740, 41771, 41772, 41773, and 81709. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected products. Consumers should contact their healthcare provider if they have received this product.

The recalled product

Product: Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Double Spike and no Probe, Ref ASC1221, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Manufacturer: Cardinal Health 200, LLC
Category: Medical Device — Surgical / Anesthesia
Hazard: functional-defect
continuous-suction
Affected units: 63,020

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

Lot numbers 11740
41771
41772
41773
and 81709.

Distribution

Distributed in 34 states:

Part of a larger recall action

This product is one of 11 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →

Same manufacturer · Cardinal Health 200, LLC

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